The Effect of Adipose-Derived Stem Cells for Knee Osteoarthritis

Recruiting

Trial ID: NCT03014401

Purpose

The purpose of this study is to compare the clinical and functional outcomes of patients with mild to moderate arthroscopically confirmed osteoarthritis between the following two groups: 1. Partial fat pad harvest with Adipose-Derived Stem Cell (ADSC) transplantation with standard arthroscopic treatment consisting of: partial meniscectomy, cartilage stabilization, loose body removal and selective synovectomy. 2. Standard arthroscopic treatment (above) without cell transplant.

Official Title

The Effect of Adipose-Derived Stem Cells for Knee Osteoarthritis: A Randomized Controlled Trial

Stanford Investigator(s)

Seth Lawrence Sherman, MD
Seth Lawrence Sherman, MD

Associate Professor of Orthopaedic Surgery

Eligibility


Inclusion Criteria:

   - Age between 35 and 70 years-old

   - Patient is scheduled to undergo one or a combination of the following procedures:

      - Meniscal debridement or partial menisectomy

      - Meniscal repair that does not necessitate a different postoperative protocol from
      meniscal debridement or partial menisectomy

      - Removal of loose bodies

      - Chondroplasty

      - Synovectomy

      - Soft tissue releases for flexion or extension contracture.

   - Diagnosis of pre-existing mild to moderate osteoarthritis of the medial or lateral
   femoral condyle (Kellgren-Lawrence Grade 2 or 3)

   - < 6 months of knee pain or < 6 months of a significant exacerbation of existing knee
   pain

   - Physical examination findings consistent with the proposed surgical procedure.

   - Failure of conservative therapy consisting of a minimum of 6 weeks of physical therapy
   and trial of anti-inflammatory medications, with or without concomitant bracing and/or
   injections

Exclusion Criteria:

   - Age < 35 or > 70 years old

   - Radiographs demonstrating either no, little or severe osteoarthritis
   (Kellgren-Lawrence Grade 0, 1 or 4)

   - Previous injury or surgery to the infrapatellar fat pad (assessed by MRI)

   - Patient scheduled to undergo any concomitant surgical procedures with the exception
   of:

      - Meniscal debridement or partial menisectomy

      - Meniscal repair that does not necessitate a different postoperative protocol from
      meniscal debridement or partial menisectomy

      - Removal of loose bodies

      - Chondroplasty

      - Synovectomy

      - Soft tissue releases for flexion or extension contracture

   - Prior surgery on ipsilateral knee involving cartilage regeneration (microfracture,
   Autologous Chondrocyte Implantation, etc) or meniscal transplant/implant

   - Previous arthroscopy within 1 year

   - Subchondral edema

Intervention(s):

procedure: Arthroscopic debridement with stem cell transplantation

procedure: Arthroscopic debridement only

Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Jason L Dragoo, MD